The Recall Desk
Severity pendingFDA (Devices)·Z-1087-2026·Announced 2026-01-21

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237

Pending LLM rewrite. Source: FDA_DEVICE Z-1087-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

The recalled product

Product
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHO
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS)
  • Lot Number 25FBK870
  • Lot Number 25EBD110
  • REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS)
  • Lot Number 25EBC253
  • Lot Number 25DBG393
  • REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS)
  • Lot Number 25FBQ303
  • Lot Number 25EBD631
  • Lot Number 25DBM322
  • REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS)
  • Lot Number 25DBT807
  • REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS)
  • Lot Number 25DMG099
  • Lot Number 25CMJ006
  • REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS)
  • Lot Number 25FDB347
  • REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS)
  • Lot Number 25EBK539
  • Lot Number 25DBD145

Distribution

Distributed nationwide across the United States.

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